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HBVaxPro (hepatitis B, recombinant surface antigen) – Labelling - J07BC01

Updated on site: 07-Oct-2017

Medication nameHBVaxPro
ATC CodeJ07BC01
Substancehepatitis B, recombinant surface antigen
ManufacturerMSD VACCINS

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

HBVAXPRO 5 micrograms - single dose vial - Pack of 1, 10

1.NAME OF THE MEDICINAL PRODUCT

HBVAXPRO 5 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (0.5 ml) contains:

 

Hepatitis B virus surface antigen, recombinant (HBsAg) * ...................

5 micrograms

Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)

* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.

3.LIST OF EXCIPIENTS

Sodium chloride, borax and water for injections.

4.PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection 1 single dose 0.5 ml vial

10 single doses 0.5 ml vials

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Shake well before use.

Read the package leaflet before use.

Intramuscular use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

9.SPECIAL STORAGE CONDITIONS

Store in a refrigerator

Do not freeze

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon France

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/01/183/001 – pack of 1

EU/1/01/183/018 – pack of 10

13.MANUFACTURER’S BATCH NUMBER

Batch

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Justification for not including Braille accepted.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING HBVAXPRO 5 micrograms - single dose vial + syringe with needle - Pack of 1

1. NAME OF THE MEDICINAL PRODUCT

HBVAXPRO 5 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (0.5 ml) contains:

 

Hepatitis B virus surface antigen, recombinant (HBsAg) * ...................

5 micrograms

Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)

* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.

3. LIST OF EXCIPIENTS

Sodium chloride, borax and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection 1 single dose 0.5 ml vial

1 sterile injection syringe with needle.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Shake well before use.

Read the package leaflet before use.

Intramuscular use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

Do not freeze

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/183/019 – pack of 1

13. MANUFACTURER’S BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

HBVAXPRO 5 micrograms

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

HBVAXPRO 5 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

IM use

2.METHOD OF ADMINISTRATION

Shake well before use

3.EXPIRY DATE

4.BATCH NUMBER

Lot

5.CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6.OTHER

MSD VACCINS

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

HBVAXPRO 5 micrograms - single dose pre-filled syringe without needle - Pack of 1, 10, 20, 50

1. NAME OF THE MEDICINAL PRODUCT

HBVAXPRO 5 micrograms, suspension for injection in pre-filled syringe

Hepatitis B vaccine (rDNA)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (0.5 ml) contains:

 

Hepatitis B virus surface antigen, recombinant (HBsAg) * ...................

5 micrograms

Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)

* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.

3. LIST OF EXCIPIENTS

Sodium chloride, borax and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

1 single dose 0.5 ml pre-filled syringe without needle 10 single dose 0.5 ml pre-filled syringes without needle 20 single dose 0.5 ml pre-filled syringes without needle 50 single dose 0.5 ml pre-filled syringes without needle

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Shake well before use.

Read the package leaflet before use.

Intramuscular use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

Do not freeze

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/183/004 – pack of 1

EU/1/01/183/005 – pack of 10

EU/1/01/183/020 – pack of 20

EU/1/01/183/021 – pack of 50

13. MANUFACTURER’S BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

HBVAXPRO 5 micrograms - single dose pre-filled syringe with 1 separate needle - Pack of 1, 10

1. NAME OF THE MEDICINAL PRODUCT

HBVAXPRO 5 micrograms, suspension for injection in pre-filled syringe

Hepatitis B vaccine (rDNA)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (0.5 ml) contains:

 

Hepatitis B virus surface antigen, recombinant (HBsAg) * ...................

5 micrograms

Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)

* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.

3. LIST OF EXCIPIENTS

Sodium chloride, borax and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

1 single dose 0.5 ml pre-filled syringe with 1 separate needle

10 single dose 0.5 ml pre-filled syringes with 1 separate needle (for each syringe)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Shake well before use.

Read the package leaflet before use.

Intramuscular use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

Do not freeze

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/183/022 – pack of 1

EU/1/01/183/023 – pack of 10

13. MANUFACTURER’S BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

HBVAXPRO 5 micrograms - single dose pre-filled syringe with 2 separate needles - Pack of 1, 10, 20, 50

1. NAME OF THE MEDICINAL PRODUCT

HBVAXPRO 5 micrograms, suspension for injection in pre-filled syringe

Hepatitis B vaccine (rDNA)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (0.5 ml) contains:

 

Hepatitis B virus surface antigen, recombinant (HBsAg) * ...................

5 micrograms

Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)

* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.

3. LIST OF EXCIPIENTS

Sodium chloride, borax and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

1 single dose 0.5 ml pre-filled syringe with 2 separate needles

10 single dose 0.5 ml pre-filled syringes with 2 separate needles (for each syringe) 20 single dose 0.5 ml pre-filled syringes with 2 separate needles (for each syringe) 50 single dose 0.5 ml pre-filled syringes with 2 separate needles (for each syringe)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Shake well before use.

Read the package leaflet before use.

Intramuscular use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

Do not freeze

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/183/024 – pack of 1

EU/1/01/183/025 – pack of 10

EU/1/01/183/030 – pack of 20

EU/1/01/183/031 – pack of 50

13. MANUFACTURER’S BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

HBVAXPRO 5 micrograms

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

HBVAXPRO 5 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

IM use

2. METHOD OF ADMINISTRATION

Shake well before use

3. EXPIRY DATE

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

0.5 ml

6. OTHER

MSD VACCINS

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

HBVAXPRO 10 micrograms - single dose vial - Pack of 1, 10

1. NAME OF THE MEDICINAL PRODUCT

HBVAXPRO 10 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (1 ml) contains:

 

Hepatitis B virus surface antigen, recombinant (HBsAg) * ...................

10 micrograms

Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)

* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.

3. LIST OF EXCIPIENTS

Sodium chloride, borax and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection 1 single dose 1 ml vial. 10 single dose 1 ml vials.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Shake well before use.

Read the package leaflet before use.

Intramuscular use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

Do not freeze

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/183/007 – pack of 1

EU/1/01/183/008 – pack of 10

13. MANUFACTURER’S BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

HBVAXPRO 10 micrograms

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

HBVAXPRO 10 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

IM use

2. METHOD OF ADMINISTRATION

Shake well before use

3. EXPIRY DATE

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

MSD VACCINS

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

HBVAXPRO 10 micrograms - single dose pre-filled syringe without needle - Pack of 1, 10

1. NAME OF THE MEDICINAL PRODUCT

HBVAXPRO 10 micrograms, suspension for injection in pre-filled syringe

Hepatitis B vaccine (rDNA)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (1 ml) contains:

 

Hepatitis B virus surface antigen, recombinant (HBsAg) * ....................

10 micrograms

Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)

* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.

3. LIST OF EXCIPIENTS

Sodium chloride, borax and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

1 single dose 1 ml pre-filled syringe without needle 10 single dose 1 ml pre-filled syringes without needle

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Shake well before use.

Read the package leaflet before use.

Intramuscular use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

Do not freeze

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/183/011 – pack of 1

EU/1/01/183/013 – pack of 10

13. MANUFACTURER’S BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

HBVAXPRO 10 micrograms - single dose pre-filled syringe with 1 separate needle - Pack of 1, 10

1. NAME OF THE MEDICINAL PRODUCT

HBVAXPRO 10 micrograms, suspension for injection in pre-filled syringe

Hepatitis B vaccine (rDNA)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (1 ml) contains:

 

Hepatitis B virus surface antigen, recombinant (HBsAg) * ....................

10 micrograms

Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)

* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.

3. LIST OF EXCIPIENTS

Sodium chloride, borax and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

1 single dose 1 ml pre-filled syringe with 1 separate needle

10 single dose 1 ml pre-filled syringes with 1 separate needle (for each syringe)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Shake well before use.

Read the package leaflet before use.

Intramuscular use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

Do not freeze

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/183/026 – pack of 1

EU/1/01/183/027 – pack of 10

13. MANUFACTURER’S BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

HBVAXPRO 10 micrograms - single dose pre-filled syringe with 2 separate needles - Pack of 1, 10, 20

1. NAME OF THE MEDICINAL PRODUCT

HBVAXPRO 10 micrograms, suspension for injection in pre-filled syringe

Hepatitis B vaccine (rDNA)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (1 ml) contains:

 

Hepatitis B virus surface antigen, recombinant (HBsAg) * ....................

10 micrograms

Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)

* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.

3. LIST OF EXCIPIENTS

Sodium chloride, borax and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection

1 single dose 1 ml pre-filled syringe with 2 separate needles

10 single dose 1 ml pre-filled syringes with 2 separate needles (for each syringe) 20 single dose 1 ml pre-filled syringes with 2 separate needles (for each syringe)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Shake well before use.

Read the package leaflet before use.

Intramuscular use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

Do not freeze

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/183/028 – pack of 1

EU/1/01/183/029 – pack of 10

EU/1/01/183/032 – pack of 20

13. MANUFACTURER’S BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

HBVAXPRO 10 micrograms

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

HBVAXPRO 10 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

IM use

2. METHOD OF ADMINISTRATION

Shake well before use

3. EXPIRY DATE

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

MSD VACCINS

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

HBVAXPRO 40 micrograms - single dose vial - Pack of 1

1. NAME OF THE MEDICINAL PRODUCT

HBVAXPRO 40 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

1 dose (1 ml) contains:

 

Hepatitis B virus surface antigen, recombinant (HBsAg) * ...................

40 micrograms

Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.50 milligram Al+)

* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.

3. LIST OF EXCIPIENTS

Sodium chloride, borax and water for injections.

4. PHARMACEUTICAL FORM AND CONTENTS

Suspension for injection 1 single dose 1 ml vial.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Shake well before use.

Read the package leaflet before use.

Intramuscular use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

9. SPECIAL STORAGE CONDITIONS

Store in a refrigerator

Do not freeze

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon France

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/01/183/015

13. MANUFACTURER’S BATCH NUMBER

Batch

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Justification for not including Braille accepted.

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

HBVAXPRO 40 micrograms

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

HBVAXPRO 40 micrograms, suspension for injection

Hepatitis B vaccine (rDNA)

IM use

2. METHOD OF ADMINISTRATION

Shake well before use

3. EXPIRY DATE

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

1 ml

6. OTHER

MSD VACCINS

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